Trial of DFP-14927 in Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03943004|
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Cancer||Drug: DFP-14927||Phase 1|
This study will determine the safety and efficacy of DFP-14927 in patients with refractory or relapsed advanced solid tumors. The study will be guided by a standard "3+3"dose escalation by observing the drug-related toxicities and dose-limiting toxicities following weekly IV infusion of DFP-14927 for each 28-day cycle (4 doses per cycle). In addition, the maximum-tolerated dose and recommended Phase II dose for DFP-14927 will be determined.
Furthermore, the study will determine the pharmacokinetics and bioavailability of DFP-14927 during the first cycle of treatment using the weekly dosing schedule.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of DFP-14927 in Patients With Advanced Solid Tumors|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||April 1, 2022|
DFP-14927: weekly IV infusion, 28 day treatment cycle
DFP-14927 is a large 4-arm-PEGylated-DFP-10917 molecule. DFP-10917 is a nucleoside analog similar to deoxycytidine.
- Determine the maximum tolerated dose (MTD) [ Time Frame: From first dose (Day 1) up to 30 days after last dose ]The highest dose level at which less than one-third of at least 6 patients (i.e., 0 or 1 out of 6) experience a DLT
- Recommended Phase II Dose (RP2D) [ Time Frame: From first dose (Day 1) up to 30 days after last dose ]The maximum tolerated dose (MTD) of DFP-14927 at which the Phase II study will explore
- Dose-Limiting Toxicity (DLT) [ Time Frame: From first dose (Day 1) up to 30 days after last dose ]Determined through the frequency/severity of adverse events per CTCAE V5.0
- Determine objective response rate (CR or PR) in response to DFP-14927 study treatment [ Time Frame: At pre-study and every 8 weeks through study completion, an average of 6 months ]Response to treatment will be assessed per RECIST 1.1
- Duration of response [ Time Frame: At pre-study and every 8 weeks through study completion, an average of 6 months ]Number of days from the time of initial response (CR or PR) to disease progression or death
- PK parameters to be determined using area under the concentration curve (AUC) [ Time Frame: Cycle 1 (each cycle is 28 days), Day 1: 0, 1, 2, 4, 8, 24, 48, and 96 hours post-dose; Day 8: 0,1, 2, 4, 8, 24, 48, and 96 hours post-dose and predose on Days 15, 22, and 29 (same as Day 1 of next Cycle) ]The concentration of DFP-14927 in blood plasma vs time
- PK parameters to be determined using maximum drug concentration (Cmax) [ Time Frame: Cycle 1 (each cycle is 28 days), Day 1: 0, 1, 2, 4, 8, 24, 48, and 96 hours post-dose; Day 8: 0,1, 2, 4, 8, 24, 48, and 96 hours post-dose and predose on Days 15, 22, and 29 (same as Day 1 of next Cycle) ]The maximum concentration of DFP-14927 in blood plasma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943004
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jaffer Ajani, MD||M.D. Anderson Cancer Center|